Bsi bs en 01283 1996

www bzfxw com | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |[.]

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

|

1283 : 1996

The European Standard EN 1283 : 1996 has the status of a

British Standard

ICS 11.040.20

NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW

Haemodialysers,

haemodiafilters, haemofilters,

haemoconcentrators and their

extracorporeal circuits

This British Standard, having

been prepared under the

direction of the Health and

Environment Sector Board, was

published under the authority of

the Standards Board and comes

into effect on

15 November 1996

 BSI 1996

The following BSI references

relate to the work on this

standard:

Committee reference CH/23

Draft for comment 94/501163 DC

ISBN 0 580 26457 2

Amendments issued since publication

British Standard

The preparation of this British Standard was entrusted to Technical Committee CH/23, Cardiovascular implants, dialysis systems and oxygenators, upon which the following bodies were represented:

Association of Anaesthetists of Great Britain and Ireland Association of British Health-care Industries

Association of Renal Technicians British Cardiac Society

British Textile Technology Group Department of Health

Institute of Physics and Engineering in Medicine and Biology Medical Sterile Products Association

National Heart and Lung Institute Renal Association

Royal College of Nursing Royal College of Physicians of London Royal College of Surgeons of England Scottish Office

Society of Cardiothoracic Surgeons of Great Britain and Ireland Society of Perfusionists (of Great Britain and Ireland)

Vascular Surgical Society of Great Britain

BS EN 1283 : 1996

Contents

Page

Annex

Figures

2 Main fitting dimensions of extracorporeal circuit connector to blood ports

3 Length of engagement of male and female cones of blood inlet and outlet

4 Main fitting dimensions of dialysing fluid inlet and outlet port 7

5 Schematic test circuit for determination of the clearances of

6 Schematic test circuit for determination of sieving coefficients of

7 Schematic test circuit for the determination of the ultrafiltration rate 12

1) In preparation.

This British Standard has been prepared by Technical Committee CH/23, Cardiovascular implants, dialysis systems and oxygenators, and is the English language

version of EN 1283 : 1996 Haemodialysers, haemodiafilters, haemofilters,

haemoconcentrators and their extracorporeal circuits published by the European

Committee for Standardization (CEN) It supersedes BS 7297 : Part 1 : 1990

Haemodialysers and related equipment Ð Part 1: Specification for haemodialysers, haemofilters and haemoconcentrators and BS 7297 : Part 2 : 1990 Haemodialysers and related equipment Ð Part 2: Specification for extracorporeal circuits for use with haemodiafilters, haemofilters and haemoconcentrators, which are withdrawn.

Cross-references

Publication referred to Corresponding British Standard

EN 556 : 1994 BS EN 556 : 1995 Sterilization of medical devices Ð

Requirements for terminally-sterilized devices to be labelled

`Sterile'

with medical devices Ð Graphical symbols for use in the labelling of medical devices1)

with medical devices Ð Information supplied by the manufacturer with medical devices1)

EN 30993-1 : 1993 BS EN 30993 Biological evaluation of medical devices

Part 1 : 1994 Guidance on selection of tests

prEN 30993-7 : 1995 BS EN ISO 10993 Biological evaluation of medical devices

Part 7 : 1996 Ethylene oxide sterilization residuals

prEN 30993-11 : 1996 BS EN ISO 10993 Biological evaluation of medical devices

Part 11 : 1996 Test for systemic toxicity

EN 46001 : 1993 BS EN 46001 : 1994 Application of EN 29001 (BS 5750 :

Part 1) to the manufacture of medical devices

EN 46002 : 1993 BS EN 46002 : 1994 Application of EN 29002 (BS 5750 :

Part 2) to the manufacture of medical devices

HD 395-2-16 : 1989 BS 5724 Medical electrical equipment

Part 2 Particular requirements for safety Section 2.16 : 1989 Specification for haemodialysis

equipment

ISO 594-2 : 1987 BS 3930 Conical fittings with a 6 % (Luer) taper for

syringes, needles and certain other medical equipment

Part 2 : 1991 Specification for lock fittings

ISO 7864 : 1988 BS 5081 Sterile hypodermic syringes and needles

Part 2 : 1993 Specification for sterile hypodermic needles for

single use

Compliance with a British Standard does not of itself confer immunity from legal obligations.

CEN

European Committee for Standardization Comite EuropeÂen de Normalisation EuropaÈisches Komitee fuÈr Normung

Central Secretariat: rue de Stassart 36, B-1050 Brussels

1996 All rights of reproduction and communication in any form and by any means reserved in all countries to CEN and its members

Ref No EN 1283 : 1996 E

ICS 11.040.20

Descriptors: Medical equipment, dialysis apparatus, haemodialysers, filters, disposable equipment, definition, specifications, performance

evaluation, physical properties, tests, information

English version

Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators

and their extracorporeal circuits

HeÂmodialyseurs, heÂmodiafiltres, heÂmofiltres,

heÂmoconcentrateurs et leurs circuits extracorporels

HaÈmodialysatoren, HaÈmodiafilter, HaÈmofilter, HaÈmokonzentratoren und dazugehoÈrige Blutschlauchsysteme

This European Standard was approved by CEN on 1996-03-14 CEN members are

bound to comply with the CEN/CENELEC Internal Regulations which stipulate the

conditions for giving this European Standard the status of a national standard

without any alteration

Up-to-date lists and bibliographical references concerning such national standards

may be obtained on application to the Central Secretariat or to any CEN member

This European Standard exists in three official versions (English, French, German)

A version in any other language made by translation under the responsibility of a

CEN member into its own language and notified to the Central Secretariat has the

same status as the official versions

CEN members are the national standards bodies of Austria, Belgium, Denmark,

Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands,

Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom

Foreword

This European Standard has been prepared by

Technical Committee CEN/TC 205, Non-active medical

devices, the Secretariat of which is held by BSI

This European Standard shall be given the status of a

national standard, either by publication of an identical

text or by endorsement, at the latest by October 1996,

and conflicting national standards shall be withdrawn

at the latest by October 1996

According to the CEN/CENELEC Internal Regulations,

the national standards organizations of the following

countries are bound to implement this European

Standard: Austria, Belgium, Denmark, Finland, France,

Germany, Greece, Iceland, Ireland, Italy, Luxembourg,

Netherlands, Norway, Portugal, Spain, Sweden,

Switzerland, United Kingdom

Page 3

EN 1283 : 1996

 BSI 1996

0 Introduction

This European Standard contains requirements and

acceptance criteria (including test methods) for

safety-related parameters for haemodialysers,

haemodiafilters, haemofilters, haemoconcentrators and

the extracorporeal circuits for these devices

This European Standard contains only those

requirements that are specific to the devices

concerned Non-specific requirements are covered by

references to other European or International

Standards, listed in the normative references section

Since non-toxicity is anticipated to be the subject of a

future standard, this standard does not cover

non-toxicity

1 Scope

This European Standard specifies requirements for

sterile, single use haemodialysers, haemodiafilters,

haemofilters, haemoconcentrators and the

extracorporeal circuits for these devices (including any

integral accessory lines, such as fluid and infusion lines

and lines for connection to pressure monitors)

intended for renal care and cardiovascular use on

humans

This European Standard does not apply to

extracorporeal circuits for cardiovascular use or to

other extracorporeal blood exchange devices, such as

plasmafilters, haemoperfusion devices, vascular access

devices, oxygenators, active medical devices or devices

for peritoneal dialysis

2 Normative references

This European Standard incorporates by dated or

undated reference, provisions from other publications

These normative references are cited at the

appropriate places in the text and the publications are

listed hereafter For dated references, subsequent

amendments to or revisions of any of these

publications apply to this European Standard only

when incorporated in it by amendment or revision For

undated references the latest edition of the publication

referred to applies

EN 556 Sterilization of medical devices Ð

Requirements for medical devices to

be labelled `sterile'

information provided with medical devices Ð Graphical symbols for use

in the labelling of medical devices

prEN 1041 Terminology, symbols and

information provided with medical devices Ð Information supplied by the manufacturer with medical devices

EN 30993-1 Biological evaluation of medical

devices Ð Part 1: Guidance on selection of tests

(ISO 10993-1 : 1992 + Technical Corrigendum 1 : 1992)

prEN 30993-7 Biological evaluation of medical

devices Ð Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7 : 1994)

prEN 30993-11 Biological evaluation of medical

devices Ð Part 11: Test for systemic toxicity

(ISO 10993-11 : 1993)

EN 46001 Quality systems Ð Medical devices Ð

Particular requirements for the application of EN 29001

EN 46002 Quality systems Ð Medical devices Ð

Particular requirements for the application of EN 29002

HD 395-2-16 Medical electrical equipment Ð

Part 2: Particular requirements for the safety of haemodialysis equipment (IEC 601-2-16 : 1989)

ISO 594-2 : 1987 Conical fittings with a 6 % (Luer)

taper for syringes, needles and certain other medical equipment Ð Part 2: Lock fittings

ISO 7864 : 1988 Sterile hypodermic needles for single

use

3 Definitions

For the purposes of this European Standard, the following definitions apply:

3.1 blood compartment

Part of haemodialysers, haemodiafilters, haemofilters and haemoconcentrators through which blood is intended to pass

3.2 clearance

Volume of a solution from which a solute is completely removed per unit time

3.3 dialysing fluid; dialysate; dialysis fluid

Solution which is intended to exchange solutes and/or water with blood during haemodialysis or

haemodiafiltration

3.4 dialysing fluid compartment

Part of a haemodialyser or haemodiafilter through which dialysing fluid is intended to pass

3.5 haemoconcentration

Process whereby excess fluid, and possibly electrolytes, are removed from diluted blood across a semipermeable membrane

3.6 haemoconcentrator

Device intended to perform haemoconcentration

3.7 haemodiafilter

Device intended to perform haemodiafiltration

3.8 haemodiafiltration

Process whereby solute imbalances in a patient's blood

are corrected by means of simultaneous filtration and

diffusion across a semipermeable membrane and

replacement with an appropriate physiological fluid

NOTE This process normally includes fluid removal.

3.9 haemodialyser

Device intended to perform haemodialysis

3.10 haemodialysis

Process whereby solute imbalances in a patient's blood

are corrected, mainly by diffusion across a

semipermeable membrane

NOTE This process normally includes fluid removal.

3.11 haemofilter

Device intended to perform haemofiltration

3.12 haemofiltration

Process whereby solute imbalances in a patient's blood

are corrected, mainly by filtration across a

semipermeable membrane and replacement with an

appropriate physiological fluid

NOTE This process normally includes fluid removal.

3.13 transmembrane pressure

Hydrostatic pressure exerted across a semipermeable

membrane

NOTE For practical reasons the mean transmembrane pressure is

generally expressed as either:

a) the difference between the arithmetic means of inlet and

outlet pressures of the blood and dialysing fluid compartments

of a haemodialyser or a haemodiafilter; or

b) the difference between the arithmetic mean of the inlet and

outlet pressures of the blood compartment and the filtrate

pressure of a haemofilter or a haemoconcentrator.

3.14 access port

Component intended to provide access to the interior

of the extracorporeal circuit

NOTE Access can be for sampling and/or injection purposes.

3.15 sieving coefficient

Ratio of a solute concentration in the filtrate to the

simultaneous concentration of the same solute in the

plasma

4 Requirements

4.1 Biological characteristics

4.1.1 Sterility and non-pyrogenicity

Pathways for blood and other fluids shall be sterile

and non-pyrogenic

NOTE The fact that it is common practice to make aseptic

connections to blood compartments and/or pathways should be

considered.

Compliance shall be verified in accordance with 5.2.1.

4.1.2 Biocompatibility

Parts of haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and the extracorporeal circuit that will come into direct or indirect contact with blood during their intended clinical use shall be

biocompatible with respect to their intended use

Compliance shall be verified in accordance with 5.2.2.

4.2 Physical characteristics

4.2.1 Structural integrity

When tested in accordance with 5.3.1, haemodialysers,

haemodiafilters, haemofilters, haemoconcentrators and extracorporeal circuits shall not leak

NOTE This requirement refers to the external integrity of the device.

4.2.2 Blood compartment integrity

When tested in accordance with 5.3.2, the blood

compartments of haemodialysers, haemodiafilters, haemofilters and haemoconcentrators shall not show leakage under the transmembrane pressures stated by the manufacturer for their intended clinical use

(see 7.2.11).

4.2.3 Connectors and ports 4.2.3.1 Connections to the blood compartment

Except if haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and the extracorporeal circuit are designed as an integral system, the dimensions of the blood inlet and outlet connectors of haemodialysers, haemodiafilters, haemofilters and haemoconcentrators shall be as given

in figures 1 and 3 and the dimensions of the connectors

of the extracorporeal circuit shall be as given in figures 2 and 3

Compliance shall be verified by inspection

4.2.3.2 Connections for dialysing fluid or filtrate

Except if haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and the dialysing fluid and/or filtrate lines are designed as an integral system, the dimensions of the ports of haemodialysers, haemodiafilters, haemofilters and haemoconcentrators shall be as given in figure 4

Compliance shall be verified by inspection

4.2.3.3 Connections to vascular access devices

Except if the extracorporeal circuit and the vascular access device are designed as an integral part, the extracorporeal circuit shall terminate in a male 6 % (Luer) taper lock fitting in accordance with ISO 594-2

Compliance shall be verified by inspection

4.2.3.4 Connections to ancillary components

Except if the extracorporeal circuit and any ancillary components are designed as integral parts and except for connectors for substitution fluid containers, the extracorporeal circuits shall terminate in a female 6 % (Luer) taper lock fitting in accordance with ISO 594-2

Compliance shall be verified by inspection

Page 5

EN 1283 : 1996

 BSI 1996

10 min

9 min

8

11 13 min

+ 0,1 - 0,2

1,2+ - 0,1

15°

15°

1 : 0,06 1)

Dimensions in mm

1) Double thread

Figure 1 Main fitting dimensions of blood inlet and outlet connections

4.2.3.5 Access ports

When tested in accordance with 5.3.3, any access

ports which incorporate a membrane intended to be

pierced by a needle and which are incorporated in the

extracorporeal circuit, shall not leak

Any access ports shall be designed so as to minimize

the risk of the needle piercing the extracorporeal

circuit completely and/or causing potential leakage

Access ports shall not be located downstream of the

intended location for any air detection device

4.2.4 Volume

When tested in accordance with 5.3.4, the volume of

the blood compartments of haemodialysers,

haemodiafilters, haemofilters, haemoconcentrators and

the volume of the extracorporeal circuit shall be within

the range of values stated by the manufacturer

(see 7.2.2).

4.2.5 Pressure drops

When tested in accordance with 5.3.5, the pressure

drops across the blood compartments of

haemodialysers, haemodiafilters, haemofilters and

haemoconcentrators and the dialysing fluid

compartments of haemodialysers and haemodiafilters

shall be within the range of values stated by the

manufacturer (see 7.2.7).

4.3 Performance characteristics

4.3.1 Clearance of haemodialysers and

haemodiafilters

When measured in accordance with 5.4.1, the

clearance rates of urea, creatinine, phosphate, cyanocobalamin and, for haemodiafilters, inulin shall

be within the range of values stated by the

manufacturer (see 7.2.6a).

4.3.2 Sieving coefficient for haemodiafilters,

haemofilters and haemoconcentrators

When measured in accordance with 5.4.2, the sieving

coefficients for albumin, inulin, myoglobin and cyanocobalamin shall be within the range of values

stated by the manufacturer (see 7.2.6).

4.3.3 Ultrafiltration rate

When measured in accordance with 5.4.3, the

ultrafiltration rate shall be within the range of values

stated by the manufacturer (see 7.2.6).

2

15°

15°

0,1 +

+ 0,075 0

11°

Dimensions in mm

Figure 2 Main fitting dimensions of extracorporeal circuit connector to blood ports of

haemodialyser, haemofilter or haemoconcentrator